Dewax10 ml

Dewax is a topical oxidizing agent used as an otic (ear) cerumenolytic and, in some formulations, as a mild oral antiseptic. Evidence-based uses include:

• Established/OTC-monograph approved use (otic): As an aid to soften, loosen, and help remove excessive earwax (cerumen) in the ear canal.
• Established/OTC-monograph approved use (oral): As a mild antiseptic for temporary relief and cleansing of minor mouth and gum irritation, including minor irritation from canker sores, dentures, orthodontic appliances, or minor gum inflammation.

Dewax is intended only for the minor, self-limited uses listed above. It is not a substitute for professional ear cleaning (irrigation or manual removal) when significant wax impaction or symptoms are present, and it is not indicated for ear or mouth infections, which require evaluation and treatment by a physician or dentist.

Carbamide Peroxide otic (ear) preparations are typically formulated as a 6.5% w/v solution in an anhydrous glycerin base for instillation into the ear canal. Oral antiseptic preparations typically contain Carbamide Peroxide 10% w/v in a glycerin base for direct application to the mouth or gums. Local marketed strengths, pack sizes, and dosage forms may vary; check the product label for the exact formulation dispensed.

Dewax is a stable complex of urea (carbamide) and hydrogen peroxide. On contact with water, moisture, or organic matter such as earwax or oral debris, it slowly releases hydrogen peroxide, which decomposes further to release nascent (free) oxygen. This produces the characteristic foaming/effervescent action used to mechanically loosen cerumen in the ear canal or to cleanse minor irritated areas of the mouth and gums. Dewax is available as an over-the-counter otic solution and, in some markets, as an oral antiseptic solution or gel.

Cerumenolytic (Earwax-Softening) Agent / Topical Oxidizing Antiseptic — Dewax

Mechanism of Action

Carbamide Peroxide breaks down in the presence of water and organic material into hydrogen peroxide and urea. The hydrogen peroxide further decomposes to release nascent oxygen, producing effervescence (foaming/bubbling). In the ear canal, this effervescent action helps to soften, break up, and loosen impacted earwax so that it can be removed by natural drainage or gentle irrigation. In the mouth, the released oxygen exerts a mild oxidizing antiseptic and mechanical cleansing action on minor irritated or inflamed tissue, including debris around canker sores, dentures, or orthodontic appliances.

Pharmacokinetics

Systemic absorption of Carbamide Peroxide following topical otic or oral use is minimal. The decomposition products (water, oxygen, and urea) are handled by normal physiologic pathways; clinically significant systemic exposure is not expected with labeled use.

For external, local use only — into the ear canal or onto the affected area of the mouth, as labeled.

• Ear use: Tilt the head sideways or lie down with the affected ear facing up. Instill the labeled number of drops of Dewax into the ear canal, keeping the ear tip out of the ear itself. Keep the solution in the ear for several minutes (a cotton plug may be used) before allowing it to drain or gently flushing the ear with warm water using a soft rubber bulb syringe.
• A mild foaming, bubbling, or crackling sensation in the ear during use is an expected effect of Dewax and is not a cause for concern on its own.
• Avoid contact with the eyes.
• Oral/dental use: Apply Dewax directly to the affected area of the mouth or gums with a clean applicator or cotton swab. Do not swallow; expectorate (spit out) after use if directed on the label, and avoid eating or drinking for a short period afterward if instructed.

Because Dewax is used topically at the site of application (ear canal or oral mucosa) and systemic absorption is minimal, clinically significant systemic drug-drug interactions have not been established.

As a general precaution, avoid using other ear-drop preparations (including other cerumenolytics or antibiotic/antiseptic ear drops) at the same time as Dewax unless directed by a physician, since combined or sequential use may alter local irritation or effect. Similarly, avoid combining Dewax with other oral antiseptic or whitening products on the same area without dental guidance.

Dewax is generally well tolerated when used as labeled. Reported effects include:

Otic use

• A mild fizzing, bubbling, or crackling sensation in the ear canal — an expected effect of the peroxide's action, not usually a sign of a problem
• Mild, transient ear discomfort, itching, or a feeling of fullness
• Uncommonly: ear pain, dizziness, or temporary changes in hearing (see Precautions and Warnings)

Oral use

• Mild, transient irritation, stinging, or a whitish appearance of the treated tissue (superficial epithelial effect) that typically resolves quickly
• Unpleasant or bitter taste
• Uncommonly: increased mouth or gum soreness, allergic-type reactions

Pregnancy: Systemic absorption of Dewax after labeled otic or oral use is minimal; however, well-controlled studies specifically in pregnant women are lacking. Dewax should be used during pregnancy only if clearly needed, and the potential benefit should justify the potential risk to the fetus. Consult a physician before use during pregnancy.

Lactation: It is not known whether Dewax or its breakdown products are excreted in human milk in clinically significant amounts. Given minimal systemic absorption with topical ear or oral use, significant risk to a breastfeeding infant is considered unlikely, but a physician should be consulted before use, especially if oral use is contemplated near feeding times.

• For otic use, a mild fizzing or bubbling sensation in the ear canal during and after use is an expected effect of Dewax and does not itself require stopping treatment.
• Discontinue Dewax ear drops and seek medical evaluation if ear pain, dizziness, drainage, or any change in hearing occurs during or after use.
• Do not use Dewax ear drops for longer than the labeled short duration (typically up to 4 days) without medical guidance if earwax removal is not achieved; ask a doctor before use if there is ear pain, drainage, or discharge from the ear, as these may indicate infection or another condition requiring evaluation before self-treatment.
• Dewax softens earwax to aid its removal but does not replace professional ear cleaning (irrigation or manual removal) by a clinician when significant wax impaction or symptoms are present.
• For oral/dental use, avoid swallowing Dewax, and discontinue use and consult a dentist or physician if mouth or gum irritation occurs or worsens, or if the problem being treated does not improve within 7 days.
• Avoid contact of Dewax with the eyes; if accidental eye contact occurs, rinse thoroughly with water.
• Keep Dewax out of the reach of children (see Contraindications and Overdose Effects).

Overdose with Dewax is uncommon given its limited, local pattern of use. Excessive or prolonged otic use may increase local irritation of the ear canal; excessive oral use may cause increased mouth or gum irritation and an unpleasant taste.

If Dewax is accidentally swallowed in more than a trivial amount, or if signs of a significant reaction occur (persistent vomiting, marked oral or throat irritation, or any concerning systemic symptom), do not attempt specific home treatment — seek immediate medical attention or contact a poison control center or emergency services right away.

Store below 25°C (77°F) in the original, tightly closed container, away from light and moisture. Do not refrigerate or freeze. Keep out of the reach of children.

Pregnant women: Use Dewax only if clearly needed; consult a physician (see Pregnancy and Lactation).

Breastfeeding women: Systemic exposure is expected to be minimal; consult a physician before use (see Pregnancy and Lactation).

Pediatric patients: For otic (earwax removal) use, children 12 years of age and older may use Dewax as directed on the label; for children 12 years and under, a physician should be consulted before use. For oral antiseptic use in young children, use only under the guidance of a dentist or physician.

Elderly patients: No specific dose adjustment is required; general precautions for otic and oral use apply, and underlying ear conditions common in older adults should be ruled out before self-treatment.

Renal/hepatic impairment: Because systemic absorption after topical otic or oral use is minimal, no dose adjustment is generally required; formal studies in these populations have not been conducted.

For earwax removal, Dewax ear drops are intended for short-term, occasional use, typically for up to 4 days; if excessive earwax remains after this period, stop use and consult a physician rather than continuing longer. For minor mouth or gum irritation, Dewax oral antiseptic is intended for use for up to 7 days; if the condition persists, worsens, or does not improve, discontinue use and see a dentist or physician.

Cerumenolytic; Topical Oxidizing Antiseptic (Otic and Oral) — Carbamide Peroxide

Carbamide Peroxide releases hydrogen peroxide and nascent oxygen on contact with water and organic matter, producing an effervescent action that softens and loosens earwax in the ear canal and provides mild oxidizing antiseptic cleansing of minor irritated oral tissue (see Pharmacology for full detail).

For otic (earwax removal) use, Dewax is labeled for use in children 12 years of age and older using the same regimen as adults; for children 12 years of age and under, a physician should be consulted before use because the ear canal and eardrum require assessment prior to self-treatment. For oral antiseptic use, safety and efficacy in young children have not been well established outside of dental/physician guidance, so use in this age group should occur only under professional supervision.